Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) is an FDA 510(k)-cleared medical device (K182172) manufactured by Medline Industries, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 2019. Regulation: 8.